RecruitingPhase 2NCT04134559

Checkpoint Inhibition In Pediatric Hepatocellular Carcinoma

The Role of Checkpoint Inhibition in Relapsed/Refractory Pediatric Hepatocellular Carcinoma: Clinical Efficacy and Biologic Correlates - A Phase II Study


Sponsor

Allison O'Neill, MD

Enrollment

18 participants

Start Date

Nov 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This research study is studying an immunotherapy drug (pembrolizumab or KEYTRUDA) as a possible treatment for pediatric hepatocellular carcinoma or hepatocellular neoplasm not otherwise specified (HCN NOS).


Eligibility

Min Age: 0 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an immunotherapy drug called pembrolizumab (a checkpoint inhibitor that helps the immune system fight cancer) in children and young adults with liver cancer (hepatocellular carcinoma or HCC) that has come back or has not responded to prior treatments. **You may be eligible if...** - You are under 30 years old - You have been diagnosed with relapsed or treatment-resistant hepatocellular carcinoma (liver cancer), confirmed by biopsy - Your cancer is measurable on imaging - Your general health performance level is adequate (Karnofsky or Lansky ≥ 60%) - Your blood counts and organ function (liver, kidney) are within acceptable levels - You agree to use contraception during and for 4 months after treatment **You may NOT be eligible if...** - You have previously received a checkpoint inhibitor (PD-1, PD-L1, or CTLA-4 inhibitor) - You are on chronic steroids or immunosuppressive medications - You have HIV, a known autoimmune disease (other than childhood asthma or eczema), or had an organ transplant - You are currently pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab will be administered every 3 weeks, at predetermined dose with 21 consecutive days defined as a treatment cycle.


Locations(5)

University of California San Francisco

San Francisco, California, United States

Children's Hospital Boston

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Baylor College of Medicine

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04134559


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